NDC 69168-430 Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen

Aspirin

NDC Product Code 69168-430

NDC CODE: 69168-430

Proprietary Name: Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspirin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a "blood thinner" to prevent blood clots.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
L
Score: 1

NDC Code Structure

  • 69168 - Allegiant Health

NDC 69168-430-99

Package Description: 365 TABLET, COATED in 1 BOTTLE

NDC Product Information

Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen with NDC 69168-430 is a a human over the counter drug product labeled by Allegiant Health. The generic name of Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen is aspirin. The product's dosage form is tablet, coated and is administered via oral form.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID (UNII: 1CS02G8656)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SHELLAC (UNII: 46N107B71O)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Allegiant Health
Labeler Code: 69168
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-14-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen Product Label Images

Aspirin 81mg Enteric Coated Low Strength Aspirin Regimen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient(S)

Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Use(S)

For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or othersymptoms needing immediate relief.

Warnings

  • Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you  are age 60 or oldertake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have had stomach ulcers or bleeding problemshave 3 or more alcoholic drinks every day while using this product  take more or for a longer time than directedtake a blood thinning (anticoagulant) or steroid drug

Do Not Use

  • If you are allergic to aspirin or any otherpain reliever/fever reducerif you have ever had an allergic reaction to this product orany of its ingredients

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou are taking a diureticyou have high blood pressure, heart disease, livercirrhosis or kidney disease  you have asthma

Ask A Doctor Or Pharmacist Before Use If

  • You are taking a prescription drug for gout  diabetesarthritis

Stop Use And Ask A Doctor If

  • An allergic reaction occurs. Seek medical help right away.you experience any of the following signs ofstomach bleeding: vomit bloodhave bloody or black stools feel fainthave stomach pain that does not get betterringing in the ears or a loss of hearing occurspain gets worse or lasts more than 10 daysredness or swelling is presentnew symptoms occurThese could be signs of a serious condition.

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Drink a full glass of water with each doseadults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctorchildren under 12 years: do not use unless directed by a doctor

Other Information

  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package

Inactive Ingredients

Corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions

Call 1-888-952-0050

* Please review the disclaimer below.